The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study

Infantile Colic Clinical Trial

Official title:

The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286737
• Other study ID #: 2019/2123
• Status: Completed
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: October 11, 2020

Study information

• Verified date: October 2020
• Source: Karamanoglu Mehmetbey University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: The purpose of this study is to determine the effect of therapeutic touch applied to infants with infantile colic on infant colic scale score, crying and sleep time.

Method: The study will be conducted as a single-blind, randomized controlled trial. The population of the study will be infants who come to the Pediatrics Outpatient Clinic and are diagnosed as infantile colic according to the evaluation of the pediatrician and have no other health problems. The infants will be divided into two groups as intervention and control groups according to stratified block randomization in the computer environment. After the randomization, therapeutic touch will be applied to the intervention group. No method will be applied to the control group.

Description:

The research will be carried out with two groups as intervention and control groups. Sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. According to the analysis results, it has been calculated as 27 for each group and 54 in total. Considering the possible case losses, 20% of the sample was increased. The sample consisted of 64 babies, 32 intervention and 32 control. Mothers of the infants meeting the study inclusion criteria will be informed both in written and verbally. Written consent will be obtained. The infants will be divided into two groups according to stratified block randomization in the computer environment. The infants will be stratified by gender and age. After the randomization, therapeutic touch will be applied to the intervention group. No method will be applied to the control group by the researcher. In obtaining research data, 4 tools will be used: "Mother-infant Information Form", "Infantile Colic Scale", Crying Time Registration Form and Sleep Time Registration Form.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 11, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Weeks

Eligibility

Inclusion Criteria:

• Family volunteering to participate in the research

• The infant was born at term

• The infant is between 4 weeks and 12 weeks

• The birth weight is between 2500-4500 g

• The infant has been diagnosed with infantile colic according to Wessel criteria

• Mothers' ability to read, write and speak Turkish

• New diagnosis of infantile colic

Exclusion Criteria:

• The infant has any chronic illness and congenital anomaly

• Mothers have diagnosed mental and mental problems

• Mother smoking

• The diagnosis of lactose intolerance to infants by the physician

Related Conditions & MeSH terms

• Colic
• Infantile Colic
• Therapeutic Touch

Intervention

Other:
• Therapeutic Touch
Therapeutic Touch will be applied to infants for 3 consecutive days, once a day, 10 minutes at any time during the day. There will be a four-day break. The Therapeutic Touch will be done a total of 6 times in 2 weeks.

Locations

Country	Name	City	State
Turkey	Karaman Education and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karamanoglu Mehmetbey University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infantile Colic Scale	Ellet et al. (2002) developed a Likert-type scale to determine the factors causing colic and to diagnose colic. Cetinkaya and Basbakkal (2007) tested the validity and reliability of the scale for the Turkish population. The scale consists of 5 sub-dimensions and 19 items.The low total score average from the scale indicates that the colic decreases, and the high average score indicates that the colic increases.	In two weeks
Secondary	Crying Time	Infants' weekly crying times will be recorded.	In two weeks
Secondary	Sleeping Time	Infants' weekly sleeping times will be recorded.	In two weeks